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Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02395172
Recruitment Status : Active, not recruiting
First Posted : March 20, 2015
Results First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: Avelumab
Drug: Docetaxel
Enrollment 792
Recruitment Details  
Pre-assignment Details First participant signed informed consent: 24 Mar 2015, Clinical data cut-off: 22 November 2017.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression. Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Period Title: Overall Study
Started 396 396
Treated 393 365
Completed 344 360
Not Completed 52 36
Reason Not Completed
Participants randomized but not treated             3             31
Treatment ongoing             49             5
Arm/Group Title Avelumab Docetaxel Total
Hide Arm/Group Description Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression. Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression. Total of all reporting groups
Overall Number of Baseline Participants 396 396 792
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 396 participants 396 participants 792 participants
62.8  (9.99) 62.5  (9.65) 62.7  (9.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 396 participants 792 participants
Female
127
  32.1%
123
  31.1%
250
  31.6%
Male
269
  67.9%
273
  68.9%
542
  68.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 396 participants 792 participants
Hispanic or Latino
59
  14.9%
42
  10.6%
101
  12.8%
Not Hispanic or Latino
297
  75.0%
307
  77.5%
604
  76.3%
Unknown or Not Reported
40
  10.1%
47
  11.9%
87
  11.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 396 participants 792 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.1%
Asian
102
  25.8%
114
  28.8%
216
  27.3%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
1
   0.1%
Black or African American
5
   1.3%
1
   0.3%
6
   0.8%
White
273
  68.9%
262
  66.2%
535
  67.6%
Not collected at the site
14
   3.5%
14
   3.5%
28
   3.5%
Other
1
   0.3%
4
   1.0%
5
   0.6%
1.Primary Outcome
Title Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)
Hide Description The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with greater than or equal to (>=) 1 percentage (%) of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 264 265
Median (95% Confidence Interval)
Unit of Measure: months
11.4
(9.4 to 13.9)
10.3
(8.5 to 13.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avelumab, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1627
Comments [Not Specified]
Method Log Rank
Comments The treatment arms were compared using a stratified, 1-sided, log rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.73 to 1.11
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS) Time in Full Analysis Set Population
Hide Description The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who were randomized to study treatment.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 396 396
Median (95% Confidence Interval)
Unit of Measure: months
10.5
(9.2 to 12.9)
9.9
(8.1 to 11.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avelumab, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1175
Comments [Not Specified]
Method Log Rank
Comments The treatment arms were compared using a stratified, 1-sided, log rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.76 to 1.07
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population
Hide Description PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with >= 1 percentage of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 264 265
Median (95% Confidence Interval)
Unit of Measure: months
3.4
(2.7 to 4.9)
4.1
(3.0 to 5.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avelumab, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5336
Comments [Not Specified]
Method Log Rank
Comments The treatment arms were compared using a stratified, 1-sided, log rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.80 to 1.27
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Progression-Free Survival (PFS) Time in Full Analysis Set Population
Hide Description PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who were randomized to study treatment.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 396 396
Median (95% Confidence Interval)
Unit of Measure: months
2.8
(2.7 to 3.5)
4.2
(3.3 to 5.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avelumab, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9561
Comments [Not Specified]
Method Log Rank
Comments The treatment arms were compared using a stratified, 1-sided, log rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.98 to 1.41
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Confirmed Best Overall Response (BOR) in Full Analysis Set Population
Hide Description Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who were randomized to study treatment.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 396 396
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
5
   1.3%
2
   0.5%
Partial Response
54
  13.6%
42
  10.6%
Stable Disease
129
  32.6%
158
  39.9%
Non-complete Response/ Non-progressive Disease
5
   1.3%
13
   3.3%
Progressive Disease
150
  37.9%
82
  20.7%
Not Evaluable
53
  13.4%
99
  25.0%
6.Secondary Outcome
Title Number of Participants With Confirmed Best Overall Response (BOR) in PD-L1+ Full Analysis Set Population
Hide Description Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with >= 1 percentage of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 264 265
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
4
   1.5%
1
   0.4%
Partial Response
46
  17.4%
30
  11.3%
Stable Disease
86
  32.6%
104
  39.2%
Non-complete Response/ Non-progressive Disease
4
   1.5%
12
   4.5%
Progressive Disease
93
  35.2%
57
  21.5%
Not Evaluable
31
  11.7%
61
  23.0%
7.Secondary Outcome
Title Percentage of Participants With Objective Response in Full Analysis Set Population
Hide Description Percentage of participants with objective response (CR plus PR) according to RECIST Version 1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who were randomized to study treatment.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 396 396
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14.9
(11.5 to 18.8)
11.1
(8.2 to 14.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avelumab, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0554
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Test the null hypothesis that there is no association between treatment effect and Objective Response Rate in at least one randomization stratum.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.40
Confidence Interval (2-Sided) 95%
0.92 to 2.13
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Objective Response in PD-L1+ Full Analysis Set Population
Hide Description Percentage of participants with objective response (CR plus PR) according to RECIST Version 1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with >= 1 percentage of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 264 265
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.9
(14.4 to 24.2)
11.7
(8.1 to 16.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avelumab, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0105
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Test the null hypothesis that there is no association between treatment effect and Objective Response Rate in at least one randomization stratum.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
1.08 to 2.86
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)
Hide Description The EQ-5D-5L health outcome questionnaire was a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defined health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score is -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest is 1.00 (no problems in all 5 dimensions).
Time Frame Baseline, End of treatment visit (up to Week 124)
Hide Outcome Measure Data
Hide Analysis Population Description
Health-related quality of life (HRQoL) analysis set was a subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline HRQoL questionnaire completed. Here, “Overall Number of Participants Analyzed” signified the participants analyzed in this outcome.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 172 196
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.1245  (0.28021) -0.0988  (0.26615)
10.Secondary Outcome
Title Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)
Hide Description EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.
Time Frame Baseline, End of treatment visit (up to Week 124)
Hide Outcome Measure Data
Hide Analysis Population Description
Health-related quality of life (HRQoL) analysis set was a subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline HRQoL questionnaire completed. Here, “Overall Number of Participants Analyzed” signified the participants analyzed in this outcome.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 171 196
Mean (Standard Deviation)
Unit of Measure: millimeter
-8.1  (22.06) -7.0  (21.12)
11.Secondary Outcome
Title Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT)
Hide Description EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Time Frame Baseline, End of treatment visit (up to Week 124)
Hide Outcome Measure Data
Hide Analysis Population Description
Health-related quality of life (HRQoL) analysis set wasa subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline HRQoL questionnaire completed. Here, “Overall Number of Participants Analyzed” signified the participants analyzed in this outcome.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 172 196
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.79  (24.506) -9.44  (18.933)
12.Secondary Outcome
Title Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT)
Hide Description EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).
Time Frame Baseline, End of treatment visit (up to Week 124)
Hide Outcome Measure Data
Hide Analysis Population Description
HRQoL analysis set, a subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline health-related quality of life (HRQoL) questionnaire completed. Here, "Number Analyzed" signified those participants who were evaluable for the specified category.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 348 333
Mean (Standard Deviation)
Unit of Measure: units on a scale
Dyspnea Number Analyzed 172 participants 197 participants
9.95  (22.094) 8.52  (21.285)
Coughing Number Analyzed 172 participants 197 participants
-0.58  (30.263) -2.03  (32.582)
Hemoptysis Number Analyzed 172 participants 197 participants
0.19  (14.191) -0.34  (16.832)
Sore Mouth Number Analyzed 172 participants 197 participants
0.78  (17.643) 3.72  (24.920)
Dysphagia Number Analyzed 172 participants 197 participants
5.62  (18.401) 4.23  (21.538)
Peripheral Neuropathy Number Analyzed 172 participants 197 participants
0.19  (20.550) 9.81  (30.015)
Alopecia Number Analyzed 172 participants 197 participants
-3.10  (20.789) 30.80  (42.582)
Pain in Chest Number Analyzed 172 participants 197 participants
4.84  (28.993) 0.34  (26.935)
Pain in Arm or Shoulder Number Analyzed 172 participants 197 participants
5.62  (28.852) 0.85  (29.439)
Pain in Other Parts Number Analyzed 171 participants 197 participants
8.77  (34.410) 6.60  (30.978)
13.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death
Hide Description An Adverse event (AE) was defined as any unfavorable and unintended sign (including clinically significant abnormal laboratory, vital signs and 12-lead Electrocardiogram findings), symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were administered at least 1 dose of the Investigational Medicinal Product.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 393 365
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
375
  95.4%
346
  94.8%
TESAEs
163
  41.5%
143
  39.2%
Drug Related TEAEs
28
   7.1%
51
  14.0%
TEAEs Leading to Death
64
  16.3%
49
  13.4%
14.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity
Hide Description Treatment Emergent Adverse Events were graded as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03). Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL), Grade 4 refers to Life-threatening consequences; where urgent intervention indicated, Grade 5 refers to the death related to adverse event.
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were administered at least 1 dose of the Investigational Medicinal Product.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 393 365
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 3 or Higher
201
  51.1%
247
  67.7%
Grade 4 or Higher
84
  21.4%
120
  32.9%
Grade 5
63
  16.0%
49
  13.4%
15.Secondary Outcome
Title Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score
Hide Description ECOG performance status measured to assess participant’s performance status on a scale of 0 to 5, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. The participants with missing worst post baseline score were also reported. ECOG performance status was reported in terms of number of participants with Baseline value vs. worst post-baseline value (i.e. highest score) combination.
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were administered at least 1 dose of the Investigational Medicinal Product.
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 393 365
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline score 0, worst post-baseline score 0
55
  14.0%
55
  15.1%
Baseline score 0, worst post-baseline score 1
64
  16.3%
41
  11.2%
Baseline score 0, worst post-baseline score 2
19
   4.8%
12
   3.3%
Baseline score 0, worst post-baseline score 3
5
   1.3%
2
   0.5%
Baseline score 0, worst post-baseline score 4
0
   0.0%
1
   0.3%
Baseline score 0, worst post-baseline score 5
1
   0.3%
0
   0.0%
Baseline score 0, worst post-baseline Missing
0
   0.0%
6
   1.6%
Baseline score 1, worst post-baseline score 0
6
   1.5%
1
   0.3%
Baseline score 1, worst post-baseline score 1
159
  40.5%
172
  47.1%
Baseline score 1, worst post-baseline score 2
48
  12.2%
41
  11.2%
Baseline score 1, worst post-baseline score 3
20
   5.1%
8
   2.2%
Baseline score 1, worst post-baseline score 4
3
   0.8%
2
   0.5%
Baseline score 1, worst post-baseline score 5
1
   0.3%
1
   0.3%
Baseline score 1, worst post-baseline Missing
12
   3.1%
23
   6.3%
16.Secondary Outcome
Title Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab
Hide Description [Not Specified]
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who were randomized to study treatment. Here, "Overall Number of Participants Analyzed" signified participants with at least on valid ADA result at any time point.
Arm/Group Title Avelumab
Hide Arm/Group Description:
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.
Overall Number of Participants Analyzed 368
Measure Type: Count of Participants
Unit of Measure: Participants
ADAs to Avelumab
51
  13.9%
NAbs to Avelumab
12
   3.3%
Time Frame Time from date of randomization up to data cutoff (assessed up to 907 days)
Adverse Event Reporting Description Safety analysis set included all participants who were administered at least 1 dose of the Investigational Medicinal Product.
 
Arm/Group Title Avelumab Docetaxel
Hide Arm/Group Description Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression. Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.
All-Cause Mortality
Avelumab Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   255/393 (64.89%)   241/365 (66.03%) 
Show Serious Adverse Events Hide Serious Adverse Events
Avelumab Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   163/393 (41.48%)   143/365 (39.18%) 
Blood and lymphatic system disorders     
Anaemia * 1  4/393 (1.02%)  3/365 (0.82%) 
Febrile bone marrow aplasia * 1  0/393 (0.00%)  1/365 (0.27%) 
Febrile neutropenia * 1  0/393 (0.00%)  22/365 (6.03%) 
Leukopenia * 1  0/393 (0.00%)  3/365 (0.82%) 
Neutropenia * 1  0/393 (0.00%)  10/365 (2.74%) 
Cardiac disorders     
Atrial fibrillation * 1  3/393 (0.76%)  0/365 (0.00%) 
Pericardial effusion * 1  3/393 (0.76%)  0/365 (0.00%) 
Cardiac arrest * 1  2/393 (0.51%)  1/365 (0.27%) 
Acute coronary syndrome * 1  1/393 (0.25%)  0/365 (0.00%) 
Angina unstable * 1  1/393 (0.25%)  0/365 (0.00%) 
Autoimmune myocarditis * 1  1/393 (0.25%)  0/365 (0.00%) 
Cardiac failure * 1  1/393 (0.25%)  0/365 (0.00%) 
Cardiac failure acute * 1  1/393 (0.25%)  0/365 (0.00%) 
Cardiac tamponade * 1  1/393 (0.25%)  0/365 (0.00%) 
Cardiomyopathy * 1  1/393 (0.25%)  0/365 (0.00%) 
Myocardial infarction * 1  1/393 (0.25%)  1/365 (0.27%) 
Acute myocardial infarction * 1  0/393 (0.00%)  1/365 (0.27%) 
Arrhythmia supraventricular * 1  0/393 (0.00%)  1/365 (0.27%) 
Cardiac failure congestive * 1  0/393 (0.00%)  1/365 (0.27%) 
Cardiovascular insufficiency * 1  0/393 (0.00%)  1/365 (0.27%) 
Ear and labyrinth disorders     
Vertigo * 1  1/393 (0.25%)  0/365 (0.00%) 
Endocrine disorders     
Adrenal insufficiency * 1  1/393 (0.25%)  1/365 (0.27%) 
Autoimmune thyroiditis * 1  1/393 (0.25%)  0/365 (0.00%) 
Eye disorders     
Vision blurred * 1  1/393 (0.25%)  0/365 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  3/393 (0.76%)  1/365 (0.27%) 
Colitis * 1  3/393 (0.76%)  0/365 (0.00%) 
Ascites * 1  1/393 (0.25%)  1/365 (0.27%) 
Diarrhoea * 1  1/393 (0.25%)  5/365 (1.37%) 
Gastric haemorrhage * 1  1/393 (0.25%)  0/365 (0.00%) 
Gastritis erosive * 1  1/393 (0.25%)  0/365 (0.00%) 
Gastrointestinal pain * 1  1/393 (0.25%)  0/365 (0.00%) 
Ileus * 1  1/393 (0.25%)  0/365 (0.00%) 
Melaena * 1  1/393 (0.25%)  0/365 (0.00%) 
Subileus * 1  1/393 (0.25%)  0/365 (0.00%) 
Constipation * 1  0/393 (0.00%)  1/365 (0.27%) 
Dysphagia * 1  0/393 (0.00%)  2/365 (0.55%) 
Ileus paralytic * 1  0/393 (0.00%)  1/365 (0.27%) 
Intestinal perforation * 1  0/393 (0.00%)  1/365 (0.27%) 
Nausea * 1  0/393 (0.00%)  2/365 (0.55%) 
Vomiting * 1  0/393 (0.00%)  1/365 (0.27%) 
General disorders     
Disease progression * 1  41/393 (10.43%)  24/365 (6.58%) 
Asthenia * 1  6/393 (1.53%)  3/365 (0.82%) 
Death * 1  6/393 (1.53%)  4/365 (1.10%) 
Pain * 1  2/393 (0.51%)  1/365 (0.27%) 
Chest pain * 1  1/393 (0.25%)  0/365 (0.00%) 
Chills * 1  1/393 (0.25%)  0/365 (0.00%) 
General physical health deterioration * 1  1/393 (0.25%)  1/365 (0.27%) 
Non-cardiac chest pain * 1  1/393 (0.25%)  1/365 (0.27%) 
Oedema peripheral * 1  1/393 (0.25%)  1/365 (0.27%) 
Fatigue * 1  0/393 (0.00%)  3/365 (0.82%) 
Malaise * 1  0/393 (0.00%)  1/365 (0.27%) 
Mucosal inflammation * 1  0/393 (0.00%)  2/365 (0.55%) 
Pyrexia * 1  0/393 (0.00%)  2/365 (0.55%) 
Sudden cardiac death * 1  0/393 (0.00%)  1/365 (0.27%) 
Hepatobiliary disorders     
Cholangitis * 1  1/393 (0.25%)  0/365 (0.00%) 
Hepatic function abnormal * 1  1/393 (0.25%)  0/365 (0.00%) 
Immune system disorders     
Hypersensitivity * 1  2/393 (0.51%)  0/365 (0.00%) 
Infections and infestations     
Pneumonia * 1  8/393 (2.04%)  19/365 (5.21%) 
Respiratory tract infection * 1  4/393 (1.02%)  5/365 (1.37%) 
Lung infection * 1  3/393 (0.76%)  2/365 (0.55%) 
Sepsis * 1  2/393 (0.51%)  2/365 (0.55%) 
Appendicitis * 1  1/393 (0.25%)  0/365 (0.00%) 
Encephalitis * 1  1/393 (0.25%)  0/365 (0.00%) 
Gastroenteritis * 1  1/393 (0.25%)  0/365 (0.00%) 
Infective exacerbation of chronic obstructive airways disease * 1  1/393 (0.25%)  0/365 (0.00%) 
Pleural infection * 1  1/393 (0.25%)  0/365 (0.00%) 
Pneumonia streptococcal * 1  1/393 (0.25%)  0/365 (0.00%) 
Postoperative wound infection * 1  1/393 (0.25%)  0/365 (0.00%) 
Bronchitis * 1  0/393 (0.00%)  4/365 (1.10%) 
Diabetic gangrene * 1  0/393 (0.00%)  1/365 (0.27%) 
Infection * 1  0/393 (0.00%)  2/365 (0.55%) 
Klebsiella infection * 1  0/393 (0.00%)  1/365 (0.27%) 
Lower respiratory tract infection * 1  0/393 (0.00%)  4/365 (1.10%) 
Meningitis * 1  0/393 (0.00%)  1/365 (0.27%) 
Neutropenic infection * 1  0/393 (0.00%)  1/365 (0.27%) 
Neutropenic sepsis * 1  0/393 (0.00%)  2/365 (0.55%) 
Peritonitis * 1  0/393 (0.00%)  1/365 (0.27%) 
Pneumocystis jirovecii pneumonia * 1  0/393 (0.00%)  1/365 (0.27%) 
Septic shock * 1  0/393 (0.00%)  5/365 (1.37%) 
Serratia infection * 1  0/393 (0.00%)  1/365 (0.27%) 
Soft tissue infection * 1  0/393 (0.00%)  1/365 (0.27%) 
Streptococcal infection * 1  0/393 (0.00%)  1/365 (0.27%) 
Upper respiratory tract infection * 1  0/393 (0.00%)  2/365 (0.55%) 
Urinary tract infection * 1  0/393 (0.00%)  1/365 (0.27%) 
Urosepsis * 1  0/393 (0.00%)  1/365 (0.27%) 
Injury, poisoning and procedural complications     
Infusion related reaction * 1  10/393 (2.54%)  0/365 (0.00%) 
Femoral neck fracture * 1  2/393 (0.51%)  0/365 (0.00%) 
Brain contusion * 1  1/393 (0.25%)  0/365 (0.00%) 
Femur fracture * 1  1/393 (0.25%)  0/365 (0.00%) 
Post procedural haemorrhage * 1  1/393 (0.25%)  0/365 (0.00%) 
Lumbar vertebral fracture * 1  0/393 (0.00%)  1/365 (0.27%) 
Spinal compression fracture * 1  0/393 (0.00%)  1/365 (0.27%) 
Investigations     
Gamma-glutamyltransferase increased * 1  1/393 (0.25%)  0/365 (0.00%) 
Neutrophil count decreased * 1  0/393 (0.00%)  4/365 (1.10%) 
Metabolism and nutrition disorders     
Hypercalcaemia * 1  3/393 (0.76%)  1/365 (0.27%) 
Hyperglycaemia * 1  3/393 (0.76%)  0/365 (0.00%) 
Hyperkalaemia * 1  2/393 (0.51%)  0/365 (0.00%) 
Decreased appetite * 1  1/393 (0.25%)  1/365 (0.27%) 
Hyponatraemia * 1  1/393 (0.25%)  0/365 (0.00%) 
Dehydration * 1  0/393 (0.00%)  2/365 (0.55%) 
Electrolyte imbalance * 1  0/393 (0.00%)  1/365 (0.27%) 
Hypokalaemia * 1  0/393 (0.00%)  1/365 (0.27%) 
Hypophagia * 1  0/393 (0.00%)  1/365 (0.27%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  2/393 (0.51%)  2/365 (0.55%) 
Arthralgia * 1  1/393 (0.25%)  1/365 (0.27%) 
Intervertebral disc protrusion * 1  1/393 (0.25%)  0/365 (0.00%) 
Osteoporotic fracture * 1  1/393 (0.25%)  0/365 (0.00%) 
Pain in extremity * 1  1/393 (0.25%)  1/365 (0.27%) 
Bone pain * 1  0/393 (0.00%)  2/365 (0.55%) 
Pathological fracture * 1  0/393 (0.00%)  1/365 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to central nervous system * 1  5/393 (1.27%)  1/365 (0.27%) 
Malignant pleural effusion * 1  2/393 (0.51%)  0/365 (0.00%) 
Metastases to bone * 1  2/393 (0.51%)  0/365 (0.00%) 
Colorectal cancer * 1  1/393 (0.25%)  0/365 (0.00%) 
Malignant neoplasm progression * 1  1/393 (0.25%)  1/365 (0.27%) 
Metastases to liver * 1  1/393 (0.25%)  0/365 (0.00%) 
Metastases to meninges * 1  1/393 (0.25%)  0/365 (0.00%) 
Metastatic neoplasm * 1  1/393 (0.25%)  0/365 (0.00%) 
Tumour pain * 1  1/393 (0.25%)  0/365 (0.00%) 
Nervous system disorders     
Depressed level of consciousness * 1  2/393 (0.51%)  0/365 (0.00%) 
Balance disorder * 1  1/393 (0.25%)  0/365 (0.00%) 
Cerebrovascular accident * 1  1/393 (0.25%)  0/365 (0.00%) 
Hemiparesis * 1  1/393 (0.25%)  0/365 (0.00%) 
Hemiplegia * 1  1/393 (0.25%)  0/365 (0.00%) 
Neurotoxicity * 1  1/393 (0.25%)  0/365 (0.00%) 
Post herpetic neuralgia * 1  1/393 (0.25%)  0/365 (0.00%) 
Seizure * 1  1/393 (0.25%)  0/365 (0.00%) 
Syncope * 1  1/393 (0.25%)  0/365 (0.00%) 
Cerebral infarction * 1  0/393 (0.00%)  1/365 (0.27%) 
Haemorrhage intracranial * 1  0/393 (0.00%)  1/365 (0.27%) 
Loss of consciousness * 1  0/393 (0.00%)  1/365 (0.27%) 
Paraesthesia * 1  0/393 (0.00%)  1/365 (0.27%) 
Spinal cord compression * 1  0/393 (0.00%)  1/365 (0.27%) 
Psychiatric disorders     
Confusional state * 1  1/393 (0.25%)  1/365 (0.27%) 
Renal and urinary disorders     
Acute kidney injury * 1  3/393 (0.76%)  2/365 (0.55%) 
Nephrolithiasis * 1  1/393 (0.25%)  0/365 (0.00%) 
Renal impairment * 1  1/393 (0.25%)  1/365 (0.27%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  11/393 (2.80%)  7/365 (1.92%) 
Pleural effusion * 1  10/393 (2.54%)  3/365 (0.82%) 
Chronic obstructive pulmonary disease * 1  5/393 (1.27%)  3/365 (0.82%) 
Pneumonitis * 1  5/393 (1.27%)  1/365 (0.27%) 
Pulmonary embolism * 1  4/393 (1.02%)  3/365 (0.82%) 
Haemoptysis * 1  3/393 (0.76%)  4/365 (1.10%) 
Interstitial lung disease * 1  3/393 (0.76%)  3/365 (0.82%) 
Respiratory failure * 1  3/393 (0.76%)  3/365 (0.82%) 
Acute respiratory failure * 1  2/393 (0.51%)  2/365 (0.55%) 
Hypoxia * 1  2/393 (0.51%)  1/365 (0.27%) 
Acute respiratory distress syndrome * 1  1/393 (0.25%)  1/365 (0.27%) 
Asphyxia * 1  1/393 (0.25%)  0/365 (0.00%) 
Atelectasis * 1  1/393 (0.25%)  0/365 (0.00%) 
Hydrothorax * 1  1/393 (0.25%)  0/365 (0.00%) 
Oesophagobronchial fistula * 1  1/393 (0.25%)  0/365 (0.00%) 
Pneumothorax * 1  1/393 (0.25%)  1/365 (0.27%) 
Pulmonary haemorrhage * 1  1/393 (0.25%)  0/365 (0.00%) 
Bronchial obstruction * 1  0/393 (0.00%)  2/365 (0.55%) 
Dysphonia * 1  0/393 (0.00%)  1/365 (0.27%) 
Dyspnoea exertional * 1  0/393 (0.00%)  1/365 (0.27%) 
Pneumonia aspiration * 1  0/393 (0.00%)  1/365 (0.27%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/393 (0.25%)  0/365 (0.00%) 
Henoch-Schonlein purpura * 1  1/393 (0.25%)  0/365 (0.00%) 
Rash maculo-papular * 1  0/393 (0.00%)  1/365 (0.27%) 
Vascular disorders     
Superior vena cava syndrome * 1  2/393 (0.51%)  1/365 (0.27%) 
Aortic aneurysm * 1  1/393 (0.25%)  0/365 (0.00%) 
Intermittent claudication * 1  1/393 (0.25%)  0/365 (0.00%) 
Peripheral arterial occlusive disease * 1  1/393 (0.25%)  0/365 (0.00%) 
Deep vein thrombosis * 1  0/393 (0.00%)  1/365 (0.27%) 
Hypotension * 1  0/393 (0.00%)  2/365 (0.55%) 
1
Term from vocabulary, MedDRA version 20.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Avelumab Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   320/393 (81.42%)   307/365 (84.11%) 
Blood and lymphatic system disorders     
Anaemia * 1  48/393 (12.21%)  81/365 (22.19%) 
Neutropenia * 1  2/393 (0.51%)  48/365 (13.15%) 
Endocrine disorders     
Hypothyroidism * 1  23/393 (5.85%)  1/365 (0.27%) 
Gastrointestinal disorders     
Nausea * 1  53/393 (13.49%)  57/365 (15.62%) 
Constipation * 1  44/393 (11.20%)  43/365 (11.78%) 
Diarrhoea * 1  41/393 (10.43%)  67/365 (18.36%) 
Vomiting * 1  36/393 (9.16%)  28/365 (7.67%) 
Stomatitis * 1  9/393 (2.29%)  42/365 (11.51%) 
General disorders     
Fatigue * 1  69/393 (17.56%)  65/365 (17.81%) 
Asthenia * 1  52/393 (13.23%)  64/365 (17.53%) 
Pyrexia * 1  48/393 (12.21%)  33/365 (9.04%) 
Chills * 1  29/393 (7.38%)  3/365 (0.82%) 
Oedema peripheral * 1  21/393 (5.34%)  37/365 (10.14%) 
Malaise * 1  9/393 (2.29%)  26/365 (7.12%) 
Mucosal inflammation * 1  5/393 (1.27%)  22/365 (6.03%) 
Infections and infestations     
Upper respiratory tract infection * 1  26/393 (6.62%)  12/365 (3.29%) 
Injury, poisoning and procedural complications     
Infusion related reaction * 1  56/393 (14.25%)  8/365 (2.19%) 
Investigations     
Weight decreased * 1  50/393 (12.72%)  30/365 (8.22%) 
Neutrophil count decreased * 1  3/393 (0.76%)  34/365 (9.32%) 
White blood cell count decreased * 1  2/393 (0.51%)  21/365 (5.75%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  78/393 (19.85%)  76/365 (20.82%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  45/393 (11.45%)  17/365 (4.66%) 
Arthralgia * 1  26/393 (6.62%)  29/365 (7.95%) 
Musculoskeletal pain * 1  24/393 (6.11%)  15/365 (4.11%) 
Pain in extremity * 1  21/393 (5.34%)  12/365 (3.29%) 
Myalgia * 1  16/393 (4.07%)  43/365 (11.78%) 
Nervous system disorders     
Headache * 1  27/393 (6.87%)  19/365 (5.21%) 
Neuropathy peripheral * 1  6/393 (1.53%)  33/365 (9.04%) 
Peripheral sensory neuropathy * 1  3/393 (0.76%)  27/365 (7.40%) 
Dysgeusia * 1  1/393 (0.25%)  23/365 (6.30%) 
Psychiatric disorders     
Insomnia * 1  19/393 (4.83%)  22/365 (6.03%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  73/393 (18.58%)  46/365 (12.60%) 
Dyspnoea * 1  71/393 (18.07%)  54/365 (14.79%) 
Productive cough * 1  24/393 (6.11%)  8/365 (2.19%) 
Haemoptysis * 1  24/393 (6.11%)  8/365 (2.19%) 
Skin and subcutaneous tissue disorders     
Rash * 1  32/393 (8.14%)  17/365 (4.66%) 
Pruritus * 1  25/393 (6.36%)  13/365 (3.56%) 
Alopecia * 1  3/393 (0.76%)  97/365 (26.58%) 
1
Term from vocabulary, MedDRA version 20.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Responsible Party: EMD Serono ( EMD Serono Research & Development Institute, Inc. )
ClinicalTrials.gov Identifier: NCT02395172     History of Changes
Other Study ID Numbers: 100070-004
2014-005060-15 ( EudraCT Number )
First Submitted: February 27, 2015
First Posted: March 20, 2015
Results First Submitted: November 20, 2018
Results First Posted: December 13, 2018
Last Update Posted: December 13, 2018